Category Archives: Enablement

Being Able to Practice the Invention is not the Same as Being Able to Practice the Full Scope of the Invention

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In Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Inc., [2020-2155, 2020-2156] (May 11, 2021), the Federal Circuit affirmed the jury determination that U.S. Patent Nos. 9,546,400 and 9,772,323 were invalid under 35 U.S.C. § 112 for lack of enablement, and the denial of a new trial because of Oxford’s improper remarks during opening remarks.

The Federal Circuit said that there was ample evidence to support a finding that, before the priority date of the ’400 and ’323 patents, relevant artisans did not know how to perform the claimed method for more than a narrow range of the full scope of nucleic acids covered by the asserted claims. The Federal Circuit said that testimony that a person skilled in the art would be able to successfully perform the method of claim 1 might not have been understood by the jury that the full scope of the claim was enabled. The Federal Circuit said that the jury’s task was not to view one portion of the testimony in isolation, but to consider all the evidence, including any portion of the evidence that might clarify how to understand other portions.

Regarding the motion for a new trial, the Federal Circuit said A new trial based on improper remarks is proper if “the appellee made prejudicial re-marks and it is ‘reasonably probable’ those prejudicial remarks influenced the jury’s verdict. The Federal Circuit saw EWe see no abuse of discretion in the district court’s determination that the opening remarks were not sufficiently likely to have influenced the jury to create a miscarriage of justice. The Federal Circuit found no abuse of discretion in the district court’s determination that the opening remarks were not sufficiently likely to have influenced the jury to create a miscarriage of justice. In particular the Federal Circuit noted that PacBio did not object in advance when it learned about the content of Oxford’s opening remarks, and mentioned the same subject in its own remarks. Further the Court gave the exact curative instruction that PacBio requested.

Synthesizing and Screening Thousands of Candidate Compounds Constitutes Undue Experimentation

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In Idenix Pharmaceuticals LLC. v. Gilead Sciences Inc., [2018-1691] (October 30, 2019), the Federal Circuit affirmed that U.S. Patent No. 7,608,597
was invalid for lack of enablement, and further held that it was invalid for lack of written description as well. A jury found that patent not invalid, and awarded damages. Gilead’s motion for JMOL was granted as to enablement, but denied as to written description.

The only independent claim of the ’597 patent recites:

  1. A method for the treatment of a hepatitis C virus infection, comprising administering an effective amount of a purine or pyrimidine β-D-2′-methylribofuranosyl nucleoside or a phosphate thereof, or a pharmaceutically acceptable salt or ester thereof.

The district court construed the structural limitation “β-D-2′-methyl-ribofuranosyl nucleoside” to require “a methyl group in the 2′ up position
and non-hydrogen substituents at the 2′ down and 3′ down positions,” while construing the preamble “[a] method for the treatment of a hepatitis C virus infection,” as a narrowing functional limitation, limiting the scope to the set of compounds that are effective for treatment of HCV.

The Federal Circuit observed that while the claim requires methyl at the 2′-up position, it allows nearly any imaginable substituent at the 2′-down position. It was undisputed that there are billions of potential 2′-methyl-up nucleosides. The key enablement question was whether a person of ordinary skill in the art would know, without undue experimentation, which 2′-methyl-up nucleosides would be effective for treating HCV. The Federal Circuit concluded they would not.

The Federal Circuit agreed with the district court that the quantity of experimentation required to determine which 2′-methyl-up nucleosides meet claim 1 was very high, favoring a finding of non-enablement. Even taking into account that a person of ordinary skill would know to eliminate certain substitutes, there was still a large number of possibilities. Even just testing the compounds expressly listed in the specification would require considerable effort.

The Federal Circuit further found that there was insufficient guidance in the specification as to which the 2′-methyl-up nucleosides will effectively treat HCV, stating that without specific guidance on that point, the specification provides “only a starting point, a direction for further research.” It is not enough to identify a “target” to be the subject of future testing. A specification that re-quires a POSA to “engage in an iterative, trial-and-error process to practice the claimed invention” does not provide an enabling disclosure.

The unpredictability of the art, and the broad scope of the claims weighed in favor of non-enablement.

Weighing each of the Wands factors, the Federal Circuit concluded as a matter of law that the ’597 patent is invalid for lack of enablement. Having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation.

On the issue of written description, the Federal Circuit, the Federal Circuit said that to fulfill the written description requirement, a patent owner must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,’ and demonstrate that by disclosure in the specification of the patent. In the context of the this case, this meant that the patent must demonstrate that the inventor was in possession of those 2′-methyl-up nucleosides that fall within the boundaries of the claim (i.e., are effective against HCV), but are not en-compassed by the explicit formulas or examples provided in the specification.

A genus can be sufficiently disclosed by features common to the members of the genus so that one of skill in the art can visualize or recognize the members of the genus, which the Federal Circuit has described as “looking for blaze marks which single out particular trees” in a forest, rather than simply “pointing to trees.”

In particular the Federal Circuit noted the conspicuous absence of any disclosure of the accused compound, saying that a POSA would not “visualize or recognize the members of the genus” as including the accused compound, and thus the specification could not demonstrate to a POSA that the inventor had possession of that embodiment at the time of filing.

Be Careful What You Wish For: Broad Claim Construction Sought by Patent Owner Results in Invalidity for Lack of Enablement

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In Trustees of Boston University v Everlight Electronics Co., Ltd., [2016-2576, 2016-2577, 2016-2578, 2016-2579, 2016-2580, 2016-2581, 2016-2582, 2016-2591, 2016-2592, 2016-2593, 2016-2594, 2016-2595] (July 25, 2018), the Federal Circuit reversed the district court’s judgment that U.S. Patent No. 5,686,738 was not invalid, because the ‘738 patent was not enabled as a matter of law.

The claim was directed to a semiconductor device comprising “a non-single crystalline buffer layer” and “a growth layer grown on the buffer layer.”  “Grown on” was construed to mean “formed indirectly or directly above” meaning that the growth layer and the buffer layer do not have to be in direct contact; there can be intervening layers between them.  “[A] non-single crystalline buffer layer” was construed to mean “a layer of material that is not monocrystalline, namely, [1] polycrystalline, [2] amorphous or [3] a mixture of polycrystalline and amorphous.  As a result of these constructions, the claim covered six possible configurations.  The enablement issue concerned one of these permutations — a monocrystalline growth layer formed directly on an amorphous buffer layer.

The district court It concluded that the ’738 patent did not have to enable a device with a monocrystalline growth layer formed directly on an amorphous buffer layer, as long as it enabled a device with a monocrystalline growth layer formed indirectly on an amorphous buffer layer.  The district court questioned whether this particular permutation was taught, but nonetheless found that a reasonable jury could have concluded that Defendants failed to show that claims were not enabled.

A patent’s specification must contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains to make and use the same.  To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.  Defendants’ expert testified that it is impossible to epitaxially grow a monocrystalline film directly on an amorphous structure, and Boston University’s expert agreed.  The Federal Circuit further noted that Boston University could not identify any portion of the specification teaching the particular permutation, and relied only on conclusory expert testimony.

While there was testimony that the a crystalline layer could be grown on an amorphous layer, the Federal Circuit instructed that the inquiry is not whether it was, or is, possible to make the full scope of the claimed device.  Instead, the inquiry is whether the patent’s specification taught one of skill in the art how to make such a device without undue experimentation as of the patent’s effective filing date. When viewed in this light, Boston University’s evidence was not probative of enablement.  Simply observing that it could be done—years after the patent’s effective filing date—bears little on the enablement inquiry.

Lastly, Boston University argued that enabling five of the six permutations was sufficient, which the Federal Circuit rejected, noting that precedent makes clear that the specification must enable the full
scope of the claimed invention.  This is not to say that the specification must expressly spell out every possible iteration of every claim.  But any gapfilling is merely supplemental; it cannot substitute for a basic enabling disclosure.

The Federal Circuit noted that Boston University created its own enablement problem — it sought a construction of “a non-single crystalline buffer layer” that included a purely amorphous layer. If it wanted to claim this, the Federal Circuit said, it should have taught it.

The Federal Circuit reversed the district court.

Antigens Don’t Describe Antibodies, and the Value of Post-Priority Date Activity on Written Description and Enablement

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In Amgen, Inc. v. Sanofi, [2017-1480](October 5, 2017), the Federal Circuit found that the district court erred by excluding Appellants’ evidence
regarding written description and enablement, and improperly instructed the jury on written description, so the Federal Circuit reversed-in-part the judgment below and remanded for a new trial on written description and enablement (concluding that defendants/appellants were not entitled to JMOL of no written description and no enablement.

The case relates to U.S. Patent Nos. 8,829,165 and 8,859,741 on  antibodies that help reduce low-density lipoprotein cholesterol (LDLC),
or “bad cholesterol.”  The district court  excluded Appellants’ evidence about antibodies, including Appellants’ infringing Praluent, developed after the patents’ priority date of January 9, 2008, reasoning that because the
evidence did not illuminate the state of the art at the time of filing,” it was not relevant “to determine whether there is sufficient disclosure of the claimed invention.”

However, the Federal Circuit found that Appellants were not offering
post-priority-date evidence to show that Appellees’ claimed genus is not enabled because of a change in the state of the art. Instead, Appellants offered Praluent and other post-priority-date antibodies to argue that the
claimed genus fails to disclose a representative number of species. As explained above, the use of post-priority-date evidence to show that a patent does not disclose a representative number of species of a claimed genus is proper. It was thus legal error for the district court to categorically
preclude all of Appellants’ post-priority-date evidence of Praluent and other antibodies. The Federal Circuit reversed the district court’s decision and remanded for a new trial on written description.

The Federal Circuit also found district court’s improper exclusion of post-priority-date evidence requires a new trial on enablement as well. Under the enablement requirement, the specification of a patent must teach
those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.  Appellants purportedly sought to introduce post-priority-date evidence showing that Appellees engaged in lengthy and potentially undue experimentation to enable the full scope of the claims. Such evidence could have been relevant to determining if the claims were enabled as of the priority date and should not have
been excluded simply because it post-dated the claims’ priority date.

The Federal Circuit turned to the jury instructions on written description.  The Federal Circuit said that the district court correctly instructed the jury that in order to satisfy the written description requirement, a patentee may disclose either a representative number of species falling within the scope of the genus or disclose structural features
common to the members of the genus so that one of skill in the art can visualize or recognize the members of the genus.  However the district court went on to instruct that “the correlation between structure and function may also be satisfied by the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties if you find that the level of skill and knowledge in the art of antibodies at the
time of filing was such that production of antibodies against such an antigen was conventional or routine.”  The Federal Circuit this instruction was not legally sound and is not based on any binding precedent.

The Federal Circuit said that this instruction improperly allowed a jury to find adequate written description merely from a finding of the ability to make and use the invention.  The Federal Circuit said that an adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.”
However, it is still contested whether the that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.  The Federal Circuit said that Section 112 requires a “written description of the invention,” not something that is not the invention.

The Federal Circuit affirmed the denial of JMOL of lack of written description and enablement, because with the exclusion of post-priority date evidence the record was incomplete to determine whether there is in fact a lack of written description and enablement.  The Federal Circuit also affirmed JMOL of non-obviousness, finding that the district court properly excluded the proffered prior art.  These references, two PCT applications were filed after the priority date, but claimed priority to provisional applications filed before the priority date.  The Federal Circuit noted that appellants did not proffer any evidence showing that the provisional applications contained representative species or common structural
elements sufficient to satisfy the written description requirement for the monoclonal antibodies claimed in the PCT applications.  Similarly, the Federal Circuit noted, Appellants provided no evidence that the claims of the PCT applications were enabled by the provisional application. Because the district court properly excluded the prior art relied upon by appellant, the court’s grant of JMOL of non-obviousness was proper.

Finally, the Federal Circuit vacated the permanent injunction because it vacated the district court’s judgment as to written description and enablement, and was remanding the case for a new trial.

Lack of Enablement in Provisional Application Results in Loss of Priority

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In Storer v. Clark, [2015-1802] (June 21, 2017) the Federal Circuit affirmed PTAB’s decision awarding priority in an interference to Clark, on the grounds that Storer’s provisional application did not enable the interference subject matter.

The subject matter in dispute involved methods of treating hepatitis C by administering compounds having a specific chemical and stereochemical structure.  Storer was issued U.S. Patent No. 7,608,600, and Clark challenged priority of invention and moved to deny Storer the priority date of its provisional application.  Clark argued that the application did not enable the claimed compound, while Storer argued that the compounds were readily obtained based on the provisional application and the prior art.

Enablement was relevant for validity and to the issue of whether the provisional application was a constructive reduction to practice.  It is a question of law, and is reviewed without deference, although the factual underpinnings of enablement are reviewed for substantial evidence.

Analyzing the disclosure under the factors set forth in In re Wands, the Board determined that undue experimentation would be required to produced the claim compounds from the provisional application’s disclosure.

The Federal Circuit began its analysis noting that the boundary between a teaching sufficient to enable a person of ordinary skill in the field, and the need for undue experimentation, varies with the complexity of the
science.   While the specification need not recite textbook science, it must be more than an invitation for further research.  Further, while the application need not disclose what is well-known in the art, it is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.

The Federal Circuit concluded that substantial evidence supported the Board’s findings that the synthetic schemes in Storer’s provisional application did not enable a person of ordinary skill to produce the target compounds without undue experimentation.

 

Plausibility vs. Enablement

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U.S. Patent No. 8,330,305 covers protecting devices from impact damage. The patent claims detecting that the portable device will impact a surface, and, if the risk of damage to the portable device from the impact exceeds a damage threshold; altering the orientation of the portable device so that the air bag will impact the surface first, and deploying the airbag before the device impacts the surface.

8330305

 

The embodiment shown appears to be a cell phone, and it is hard to imagine that a reasonably sized cell phone could contain both an airbag and a system that could reorient the cell phone in a ~42 inch drop from the hands of a user.  In 7200 words and a dozen figures, the disclosure seems to barely meet the plausibility threshold, let alone enablement required under 35 USC 112(a).